CRA

Inno Medicine; United States; Remote; USD 75,000 - 110,000; Full time

Job summary

Innomed is seeking a remote, full-time Clinical Research Associate to oversee study-related activities across multiple protocols. You will address site issues, ensure protocol and regulatory compliance, and support budget and regulatory submissions while traveling up to 75% domestically.

The role requires a life sciences degree and at least one year of CRA experience; Phase 3 exposure and knowledge of GCP/ICH guidelines are preferred.

Qualifications

• Bachelor's degree in life sciences, healthcare, or equivalent work experience.
• Minimum of one year of CRA experience in a medical, pharmaceutical, or CRO setting preferred.
• Phase 3 double-blinded experience is preferred.
• Knowledge of industry-sponsored clinical research preferred.

Responsibilities

• Addresses study-related clinical site issues with appropriate guidance.
• Initiates and communicates corrective action as indicated.
• Supports the organization, management, and execution of projects.
• Identifies non-adherence and ensures compliance with protocols and regulations.
• Participates in study startup, conduct, and closure tasks.
• Manages activities of clinical investigative sites across multiple protocols.
• Ensures integrity and quality of data submitted from study sites.
• Trains study site personnel on protocols and regulatory requirements.
• Facilitates Quality Assurance audit processes.
• Prepares and submits accurate monitoring and administrative reports.
• Supports Clinical Trial Application submissions.
• Assists with study budget preparation and clinical trial agreement execution.
• Supports continuous improvement initiatives within Clinical Operations.
• Promotes a "White Glove Service" culture in stakeholder engagement.

Skills

Planning

Organization

Analytics

Communication

Education

Bachelor's degree in life sciences, healthcare, or equivalent work experience

Job description

Innomed is a clinical-stage biotechnology company focused on the development of first-in-class and best-in-class cardiovascular and metabolic innovative therapies, leveraging proprietary drug delivery and translational platforms. The company is preparing for HK IPO, with active multi-regional clinical trials in China, the US, Canada and Australia.

About the Role

Fully remote; Full time; Full benefits; Need to travel; annual pay $75,000 to 110,000. The position addresses study-related clinical site issues with appropriate guidance, initiates and communicates corrective action as indicated. They will use functional expertise and exercise good judgment in seeking appropriate guidance and ensure that follow-up to any and all corrective action taken is properly documented to ensure the safety, welfare, and rights of patients are protected. Supports the organization, management, and execution of projects; identifies non-adherence and ensures clinical trials are conducted, recorded, and reported in accordance with the protocol, federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, company’s Standard Operating Procedures (SOPs), Monitoring Plans, and quality standards. Understands the rationale and necessity for compliance to ensure protection of the safety, welfare, and rights of patients. May require guidance/oversight to manage effectively. Actively participates in study startup activities, site opening activities, study conduct, and site closure tasks. Manages activities of clinical investigative sites across multiple protocols and therapeutic areas, with appropriate supervision. Ensures integrity and quality of data submitted from study sites and assures timely submission, including appropriate reporting and follow-up for all safety events. Expected to conduct independent monitoring visits (at least 1 year of clinical research monitoring experience required). Supports and/or conducts on-site and remote monitoring visits (qualification, initiation, interim monitoring, and closeout) for Phase 1-4 studies in accordance with GCPs, ICH Guidelines, and SOPs. Trains study site personnel on protocols and regulatory requirements in collaboration with project teams; escalates serious or outstanding issues appropriately. Facilitates Quality Assurance audit processes and ensures regulatory inspection readiness at assigned sites. Prepares and submits accurate monitoring and administrative reports with appropriate supervision. May support Clinical Trial Application submissions, including informed consent updates and translations. May assist with study budget preparation and clinical trial agreement execution; negotiates investigator/hospital agreements. Maintains expense reports per guidelines. Supports continuous improvement initiatives to enhance quality, productivity, and efficiency within Clinical Operations. Promotes a "White Glove Service" culture with strong sponsor/site service mindset in stakeholder engagement, including investigative sites. Location: Remote within the United States Travel: Up to 75% domestic travel required.

Responsibilities

• Addresses study-related clinical site issues with appropriate guidance.
• Initiates and communicates corrective action as indicated.
• Supports the organization, management, and execution of projects.
• Identifies non-adherence and ensures compliance with protocols and regulations.
• Participates in study startup, conduct, and closure tasks.
• Manages activities of clinical investigative sites across multiple protocols.
• Ensures integrity and quality of data submitted from study sites.
• Trains study site personnel on protocols and regulatory requirements.
• Facilitates Quality Assurance audit processes.
• Prepares and submits accurate monitoring and administrative reports.
• Supports Clinical Trial Application submissions.
• Assists with study budget preparation and clinical trial agreement execution.
• Supports continuous improvement initiatives within Clinical Operations.
• Promotes a "White Glove Service" culture in stakeholder engagement.

Qualifications

• Bachelor’s degree in life sciences, healthcare, or equivalent work experience.
• Minimum of one year of CRA experience in a medical, pharmaceutical, or CRO setting preferred.
• Phase 3 double-blinded experience is preferred.
• Knowledge of industry-sponsored clinical research preferred.
• Understanding of ICH/GCP Guidelines and applicable regulations preferred.
• Strong planning, organizational, analytical, and communication skills.
• Ability to work effectively in a fast-paced environment with competing priorities.
• Demonstrated business ethics, integrity, and sound judgment.

Required Skills

• Strong planning, organizational, analytical, and communication skills.
• Ability to work effectively in a fast-paced environment with competing priorities.
• Demonstrated business ethics, integrity, and sound judgment.

Preferred Skills

• Cardiovascular (cardio) and oncology clinical trial experience is preferred.
• Spanish bilingual proficiency is preferred.

Pay range and compensation package

Annual pay $75,000 to 110,000.

Equal Opportunity Statement

We are committed to diversity and inclusivity in our hiring practices.